BB536 is a Human-Residential Bifidobacterium (HRB) strain studied for its effects on promoting a healthy gut microbiota and immune development. There are currently more than 200 scientific studies of BB536 and its beneficial effects on infant, children, adult and senior health.
In 2016, Bing-Bing Wu et al., reported that BB536 (1x107 CFU/g) given to healthy newborns for six months had positive effects on establishing a healthy gut microbiota early in life, leading to improved immune development in infants. The RCT involving 300 newborns was published in the World Journal of Pediatrics.
Another study by Tadao Enomoto et al., in 2014 reported BB536 helped reduce the risk of developing eczema or atopic dermatitis in infants. BB536 (1x1010 CFU/g) was given prenatally to mothers for one month, and post-natal in doses of 5x109 CFU/day for six months to infants after they were born. The study was published in Allergology International.
The firm was the winner of the Editors Award for Infant & Child Nutrition of the Year at the recent NutraIngredients-Asia Awards 2020.
Dr Abe Fumiaki, corporate officer and general manager of food ingredients and technology at Morinaga Milk commented: “We are honoured that the industry has once again recognised the scientific rigor of our proprietary HRB probiotic strains.”
“Over the past few decades, we have been striving to contribute to the health of babies around the world by supplying health-promoting probiotic ingredients. I am pleased that our efforts have been recognised. This award is another acknowledgement of the quality of science, innovation, commercial success, and market potential of our HRB probiotics in infant nutrition market.”
Untapped opportunity
Last year, BB536 obtained an FDA GRAS approval for use in infant formula in 2019, after its GRAS notification for general foods back in 2009.
BB536 is currently incorporated into many of Morinaga’s finished products, including yogurt, drink-type yogurt, non-fermented milk, adult milk formula, dietary supplements in the forms of capsule and tablet, infant formula, and growth-support drink for children.
According to Dr Chyn Boon Wong, research associate at Morinaga Milk Industry: “Acquisition of the FDA GRAS approval was a stepping stone to expand the opportunities of BB536 to be specifically used in infant formulas.”
In September 2020, Morinaga Milk relaunched its follow-up milk formula (Morinaga Chil Mil) for children one to three years. It was Japan’s first bifidobacteria-fortified infant formula in Japan, containing BB536 and another probiotic strain M-16V.
According to Wong, Morinaga Milk had received approval from Japan’s Ministry of Health, Labour and Welfare to use bifidobacteria in infant formula, which was the first for Japan.
Previously, Morinaga Chil Mil did not contain any bifidobacterial. The relaunched follow-up milk formula is marketed to support healthy intestinal environment in children.
In children, an RCT demonstrated that BB536 supplementation (3x109 CFU/day) for four weeks was effective at alleviating allergic rhinitis symptoms in children with pollen-induced allergic rhinitis and intermittent asthma. The 2017 study by Michele Miraglia Del Giudice et al, was published in the Italian Journal of Pediatrics.
Another study by Giannetti Eleonora et al in 2017 reported that BB536 was effective at alleviating irritable bowel syndrome in children. The findings were published in the Journal of Clinical Gastroenterology.
Wong told us that the infant probiotic space was a “unique and relatively untapped domain.”
Besides consumer products, the company also sells BB536 as a functional probiotic ingredient under its B2B business.
Wong added: “We are expanding BB536's B2B infant nutrition business in North America, Europe, and Asia-Pacific including the ever-growing China market.”
“We believe with the uniqueness of our probiotic strains (human-residential origin, highly safe, regulatory compliance, quality assurance, proven efficacy, and excellent stability) would gain more tractions in infant nutrition application as consumers demand for naturalness continue to rise.”